Ep. 351 - Gilead's Arcellx Buy. Plus: ctDNA as Surrogate Endpoint

Gilead is acquiring Arcelex for nearly $8,000,000,000 upfront a little more than three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. We take a look at the deal on this week's BioCentury This Week podcast. Plus, optimization and validation are needed to achieve ctDNA's highest priority application, surrogate endpoints for early cancer trials. And we'll have Steve Austin's takeaways from last week's pharma forum. Steve also gives his point of view on FDA's Moderna u-turn. I'm Jeff Kranmer, host of the BioCentury This Week podcast. And joining me today are my colleagues. Paul Bananos, director of Biopharma Intelligence. Lauren Martz, executive director of Biopharma Intelligence. Simone Fishburne, editor in chief. And Steve Austin, Washington editor. Okay. We have the BioCentury Bay Helix East West Summit coming up in a matter of weeks in Seoul. We're hoping to see you there. We're going to introduce a new exclusive opportunity for our subscribers, the BioSentry Lounge. It will be a cool dedicated space designed to connect, recharge, and inspire conversation among industry leaders. Also at the conference, if you're going well, it's not too late, you know. I realize it's a little bit of a ways, from France or Washington, and folks in the Northeast are probably gonna be snowed under for quite some time and unable to get to the airport. But if you're in Japan, elsewhere in Korea, China, hop on a plane and head over to Seoul to join us. We will have a special excursion on the heels of the conference to Daejeon. It's been called Korea's Silicon Valley. It's included in the price of admission for the conference, and you'll get to visit local biotechs and network with industry leaders in Daejeon. You can RSVP right now to our colleague Brian Denker at conferences@biocentury.com. It's gonna be a great trip, and we hope to see you at the East West Summit. Alright. Gilead acquiring Arcelex, 7,800,000,000.0. Paul, you've been looking into this. What have you found? Sure. Well, as you said, Arcelex has already partnered with Gilead. So in a way, Gilead is sort of buying out the rest of the economics in its own deal. And most of that deal from 2022 has centered on a CAR T therapy called AnitoCell. I'll spare you the longer name. There is a longer name, but we'll use that one today, AnitoCell. And like a couple of other CAR Ts for multiple myeloma that are already approved, it has a familiar target, BCMA, the same as the ones from Johnson and Johnson and Bristol. Arcellx uses a different binding technology of its own, and the company believes that that confers advantages, in safety. There's a lack of, certain neurotoxicities, for example, Parkinson's seen in relatively low rates for, Carvicti, that's the j and j one, And also manufacturing, they say that they can, produce shorter turnaround times. J and J has had some difficulty scaling up over the years to meet demand, …